MAUDE Adverse Event Report: SYNTHES USA; PROSTHESIS, ELBOW, RADIAL, HEMI, POLYMER

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

(b)(6).The original implant date was approximately six (6) months prior to the removal date.Complainant device is not expected to be returned for manufacturer review/investigation.Therapy date is approximately six (6) months prior to the removal date.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a hardware removal of radial head prosthesis was performed on (b)(6) 2017.The removal was performed due to implant loosening and a significant amount of osteolysis around the implant stem.The original implant date was approximately six (6) months prior to the removal date.Removed hardware included the radial head and radial stem, both fully intact and in one piece.The patient was not revised to any other device.The procedure was completed successfully with the patient in stable condition.Concomitant devices reported: radial head (part # unknown, lot # unknown, quantity 1).This report is for one (1) unknown radial stem.This is report 1 of 1 for complaint (b)(4).

• Type of Device: PROSTHESIS, ELBOW, RADIAL, HEMI, POLYMER
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6740011
• MDR Text Key: 80921351
• Report Number: 2520274-2017-11961
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: RADIAL HEAD (PART # UNKNOWN, LOT # UNKNOWN, QTY 1)
• Patient Outcome(s): Required Intervention